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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05947968
Other study ID # Lateral epicondylitis
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date October 2023

Study information

Verified date July 2023
Source Cairo University
Contact Mahmoud Ghallab, Master
Phone 00201001899452
Email mahmoudasam93@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare between the effect of scapular proprioceptive neuromuscular facilitation versus shoulder and scapular strengthening exercise on pain, functional outcome and grip strength in patients with lateral epicondylitis.


Description:

There is no standard treatment for lateral epicondylitis, it is always a combination of physical therapy modalities aimed to reduce pain and increase the ability to return functional activities participation. Accordingly, many researchers have added shoulder strengthening exercise to the rehabilitation plan for treating lateral epicondylitis. Consequently, development of new concept of scapula motor control exercise using proprioceptive neuromuscular facilitation to add proximal stability to patients with lateral epicondylitis may be beneficial. We believe that this study can serve as a step toward documenting the evidence of scapular proprioceptive neuromuscular facilitation exercise in the treatment of patients with lateral epicondylitis which was not available before. Patients with lateral epicondylitis will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form. After group assignment, patients' demographics will be collected, and then assessment of pain, function and grip strength will be performed. The same assessment procedure will be conducted by the end of the treatment (by the end of the 12th visit). The study will be two comparative groups, pre-post experimental design, the subjects will be randomly assigned into one of two groups: - Group (I) : will receive scapular proprioceptive neuromuscular facilitation exercises. - Group (II) : will receive shoulder strengthening exercises.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date October 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients will be included if they have the following criteria: - Fifty-two male and female subjects. - Patients complaining of chronic lateral epicondylitis (more than three months). - Age between 20-50. Exclusion Criteria: - Patients will be excluded if they had any of the following conditions: - Received physiotherapy in last 3 months. - Received corticosteroids injection in lateral epicondyle in last 3 months. - Receiving anti-inflammatories medications on regular basis. - Had neurologic problems in shoulder, neck and thoracic regions. - Had history of rheumatic disease. - Had cooperation difficulties due to cognitive disorders. All Patients will be instructed to keep away from activities that aggravate the symptoms such as grasping, lifting, knitting and using a screwdriver during the treatment period.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Scapular PNF
Scapular proprioceptive neuromuscular facilitation exercise: will be applied in two diagonals: anterior elevation and posterior depression posterior elevation and anterior depression for 3 sets of 10 repetitions, The rest interval between sets will be 20 seconds. Patients will lay on the unaffected side while the therapist stands in the line of desired motion. Firstly, the therapist will give preparatory instructions. In the beginning of the pattern, the therapist pulls the scapula to the elongated position and then gives instructions for the desired movement.
Shoulder strengthening exercises
Shoulder strengthening exercises: The following four exercises will focus on shoulder and scapular strengthening. Before starting the program, the patients will be thoroughly instructed in the four exercises, and illustrations with specific exercise instructions will be provided. All subjects will perform the exercises with the affected side for three sets of 10 repetitions for each exercise, with a 1-minute rest between sets. Standing shoulder external rotation with elastic resistance. Bilateral external rotation with scapular retraction exercise. Resisted scapular retraction with shoulder external rotation (Middle trapezius muscle). Weighted scapular retraction and downward rotation Y-shape (lower trapezius muscle).

Locations

Country Name City State
Egypt Cairo University Giza

Sponsors (2)

Lead Sponsor Collaborator
Mahmoud Essam Abu Elfetouh Ghallab Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity by The Numeric Pain Rating Scale (NPRS) (NPRS) is a unidimensional measure of pain intensity in adults. Consists of 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable. one month
Primary Pain and functional disability by patient-rated tennis elbow evaluation (PRTEE) The PRTEE is a valid and reliable tool that may be used in both research and clinical settings to assess the subjective outcome in patient with lateral epicondylitis. Subjects will be asked to rate the level of discomfort and difficulty they had encountered in the previous week. High total scores imply more pain and impairment; the scale spans from 0 to 100.
The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with LE. The PRTEE allows patients to rate their levels of pain and disability from 0 to 10, and consists of 2 subscales:
PAIN subscale (0 = no pain, 10 = worst imaginable)
• Pain - 5 items
FUNCTION subscale (0 = no difficulty, 10 = unable to do)
Specific activities - 6 items
Usual activities - 4 items
one month
Primary Grip strength by Jammar handheld dynamometer. The Jammar hand grip dynamometer is valid and reliable, will be used to assess the subject's pain-free grip strength while they are lying on their side with their elbow extended and pronated. Subjects will be instructed to squeeze the dynamometer handles until they experienced pain. It will be performed three times with 20 s rest period between repetitions. Average of three trials will be recorded in kilograms. one month
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